Mobile Health App for Mental Health Issues

No longer recruiting at 1 trial location

Overseen By Tracey Churay, MS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Michigan

Disqualifiers: Not enrolled, Non-compliance, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how a mobile health app featuring positive activities, combined with wellness coaching, impacts the mental health of college students. Researchers seek to determine whether using the app alongside coaching proves more effective than coaching alone. This study will provide insights into the optimal combination of digital and in-person support for students. The trial seeks participants who are college students at the University of Michigan or in the STEER program, possess a smartphone, and can receive study materials by mail. As an unphased trial, it offers students an opportunity to contribute to innovative research that could enhance mental health support.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this mobile health app is safe for mental health interventions?

Research has shown that mobile health apps with activities that boost positive thinking are generally safe for users. Studies have found that these apps can improve mental health by reducing stress and anxiety. They achieve this by promoting positive thinking and helping users manage their emotions.

Using these apps alongside wearable devices might further enhance both mental and physical health. Designed for everyday people, not just those with specific health issues, these apps are suitable for most users.

Although evidence on some specific mental health outcomes remains limited, the overall safety of these apps is positive. They provide support without any known serious side effects, making them a promising option for anyone interested in improving their well-being through digital tools. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mobile health app for mental health issues because it integrates positive psychological activities directly into daily life through a convenient platform. Unlike traditional therapy or medication, this app encourages proactive engagement by combining wellness coaching with real-time feedback from a wearable device. Participants can track their steps and sleep, but the standout feature is the personalized positive activities designed to boost mental well-being. This innovative blend of technology and psychology could make mental health support more accessible and engaging, potentially leading to better outcomes compared to standard treatments.

What evidence suggests that this mobile health app is effective for mental health issues?

Research has shown that mental health apps can improve mental well-being. In a study of 35 apps, 32 helped with issues like depression, anxiety, and suicidal thoughts. Another study found that these apps can reduce stress and anxiety while enhancing overall well-being. Reviews of multiple studies indicate that mindfulness and positive activities in these apps can enhance users' mental health and emotional control. In this trial, one group of participants will use a mobile health app with positive activities, which might improve mental health for college students. Another group will use a limited version of the app without positive activities. ^{1 2 5 6 7}

Who Is on the Research Team?

Sung Won Choi, MD, MS

Principal Investigator

University of Michigan

Are You a Good Fit for This Trial?

This trial is for college students experiencing mental health issues. Participants should be willing to use a mobile health app and receive wellness coaching. Specific eligibility criteria are not provided, so it's assumed that any student facing mental health challenges could potentially participate.

Inclusion Criteria

Must have the ability to understand and demonstrate willingness to remotely sign a written informed consent document

Students must be either enrolled at the University of Michigan OR in the STEER transition program

Must possess a smartphone (Apple or Android)

Exclusion Criteria

People who are not enrolled in classes at the University of Michigan OR people who are not members of the STEER organization

I am willing and able to follow the study's procedures.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants engage in wellness coaching and use the Roadmap 2.0 app, with or without positive psychological activities, and track their daily step count and sleep hours.

4 months

Monthly surveys and exit interview

Follow-up

Participants are monitored for mental health outcomes and survey completion rates after the intervention period.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mobile Health App with Positive Psychological Activities

Trial Overview The study is testing the effectiveness of a mobile health app with positive psychological activities combined with wellness coaching versus just wellness coaching alone on improving college students' mental health outcomes.

How Is the Trial Designed?

Group I: Wellness coaching plus mobile health app (positive activities) Experimental Treatment 1 Intervention

Participants will participate in wellness coaching and receive a wearable device, and they will be assigned to use the mobile health app with positive psychological activities installed. Additionally, participants can view their daily step count and number of hours of sleep in the mobile health app.

Group II: Wellness coaching plus limited mobile health app (no positive activities) Active Control 1 Intervention

Participants will participate in wellness coaching and receive a wearable device, but will be assigned to use the mobile health app WITHOUT positive psychological activities installed. Participants can only view their daily step count and number of hours of sleep in the mobile health app.

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

STEER for Student Athletes

Collaborator

Trials

1

Recruited

90+

Published Research Related to This Trial

A meta-analysis of 19 trials involving 3681 participants found that standalone smartphone apps significantly reduced symptoms of depression and smoking behavior, with effect sizes indicating moderate efficacy (Hedges' g = 0.33 for depression and g = 0.39 for smoking).

However, the analysis did not find significant effects for anxiety, suicidal ideation, self-injury, or alcohol use, suggesting that while some apps may help with specific issues, they cannot be recommended as standalone treatments for mental health based on current evidence.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone smartphone apps for mental health-a systematic review and meta-analysis. Weisel, KK., Fuhrmann, LM., Berking, M., et al.[2020]

The mindLAMP app, when used with cognitive behavioral therapy (CBT) skills, showed a small but positive effect on reducing anxiety and depression symptoms compared to a control version focused only on self-assessment, with 328 participants in the control group and 156 in the intervention group.

The effect sizes were modest, with Hedge's g values of 0.34 for anxiety and 0.21 for depression, indicating that while the app shows promise, further research with a larger sample size is needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An exploratory analysis of the effect size of the mobile mental health Application, mindLAMP. Chang, S., Alon, N., Torous, J.[2023]

Standalone smartphone-based ecological momentary interventions (EMIs) based on cognitive behavioral therapy (CBT) principles have been shown to significantly improve well-being and reduce mental health symptoms among users, according to a review of 26 studies.

Users rated these EMIs as helpful and satisfying, indicating their potential as scalable and accessible mental health support, especially important during global crises like the COVID-19 pandemic.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Standalone Smartphone Cognitive Behavioral Therapy-Based Ecological Momentary Interventions to Increase Mental Health: Narrative Review. Marciniak, MA., Shanahan, L., Rohde, J., et al.[2020]

The gamified mobile mental health app eQuoo significantly improved resilience, personal growth, and psychological well-being in 358 participants over a 5-week randomized controlled trial, compared to control groups.

With a high adherence rate of 90%, eQuoo retained 21% more participants than the control or waitlist groups, suggesting that gamification can enhance engagement and reduce dropout rates in mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Gamification as an approach to improve resilience and reduce attrition in mobile mental health interventions: A randomized controlled trial. Litvin, S., Saunders, R., Maier, MA., et al.[2020]

In a pilot study involving 33 veterans, the Moving Forward app was tested alongside problem-solving therapy (PST) and showed high satisfaction and reductions in depression, anxiety, and stress among participants.

Veterans using the app reported effective skills practice and found it valuable, suggesting that the app could help reduce barriers to mental health care in primary care settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Enhancing Problem-Solving Therapy With Smartphone Technology: A Pilot Randomized Controlled Trial. Grubbs, KM., Abraham, TH., Pyne, JM., et al.[2022]

A review of 92 mental health apps for depression and anxiety revealed that half did not meet basic accessibility standards, and 20% failed to ensure security and privacy, raising concerns about their safety and effectiveness.

Only one app out of the most visible ten on app stores met all quality criteria, indicating a disconnect between app popularity and actual quality, which could mislead vulnerable users seeking mental health support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic assessment of the quality and integrity of popular mental health smartphone apps using the American Psychiatric Association's app evaluation model. Rickard, NS., Kurt, P., Meade, T.[2022]

Mobile health apps are increasingly popular for delivering healthcare services and interventions, providing benefits across various medical specialties, but they also come with potential risks that need careful consideration.

There is a critical need to study and report the safety and adverse effects of mobile apps, particularly those delivering psychosocial interventions, focusing on privacy, security, and unique digital interactions, as this is a relatively new area requiring further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting and understanding the safety and adverse effect profile of mobile apps for psychosocial interventions: An update. Naeem, F., Gire, N., Xiang, S., et al.[2020]

A review of 92 mental health screening and diagnostic apps revealed that while 65% of user reviews were positive, many apps suffer from high dropout rates due to issues with functionality and accessibility.

Common features like mood tracking were present in 74% of the apps, but improvements in performance and user experience are needed to enhance sustained use and effectiveness in supporting mental health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

mHealth Solutions for Mental Health Screening and Diagnosis: A Review of App User Perspectives Using Sentiment and Thematic Analysis. Funnell, EL., Spadaro, B., Martin-Key, N., et al.[2022]

A pilot study involving 31 participants identified five distinct patterns of engagement with the HabitWorks app, highlighting the complexity of user interaction with mental health interventions.

The study emphasizes the importance of understanding engagement as a multifaceted construct, which can inform the design and effectiveness of mental health apps like HabitWorks.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Operationalizing Engagement With an Interpretation Bias Smartphone App Intervention: Case Series. Ramadurai, R., Beckham, E., McHugh, RK., et al.[2022]

A scoping review of 14 studies involving 1205 participants found that mental health mobile apps, particularly those based on cognitive behavior theory, effectively reduced stress, depression, and anxiety in adults over 18.

Despite the promising results, the review highlighted a lack of well-designed, theory-based apps and called for more randomized control trials to ensure the effectiveness and safety of these mental health interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Research Trends on Mobile Mental Health Application for General Population: A Scoping Review. Hwang, WJ., Ha, JS., Kim, MJ.[2021]

In a study involving 238 users of the MoodMission app over 30 days, it was found that higher engagement with the app's activities was linked to more positive evaluations of those activities, indicating that user engagement is crucial for the app's effectiveness.

The study also suggested that using visual psychoeducation in behavioral activation interventions may enhance user engagement compared to written psychoeducation, highlighting the importance of how information is presented in mental health applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Engagement with smartphone-delivered behavioural activation interventions: a study of the MoodMission smartphone application. Aizenstros, A., Bakker, D., Hofmann, SG., et al.[2021]

The PUSH-D app, a self-help intervention for depression developed for urban Indians, showed significant reductions in depression and improvements in functioning among 78 participants, most of whom had never sought professional help.

Pilot testing indicated that participants who completed all 10 essential sections of the app maintained their improvements at follow-up, suggesting that this app could effectively address the treatment gap for depression in India.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Pilot Testing of an Internet-Based Self-Help Intervention for Depression for Indian Users. Mehrotra, S., Sudhir, P., Rao, G., et al.[2020]

In a study involving 626 adults with mild to moderate depression, mobile apps designed for mental health showed significant benefits, particularly for those with more severe symptoms, indicating their potential effectiveness in improving mood.

Among the tested apps, the cognitive training app (Project: EVO) demonstrated the strongest impact on mood compared to a control app, suggesting that engaging cognitive processes can enhance the therapeutic effects of mobile interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Use and Effectiveness of Mobile Apps for Depression: Results From a Fully Remote Clinical Trial. Arean, PA., Hallgren, KA., Jordan, JT., et al.[2019]

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